OncoMatch/Clinical Trials/NCT06537154
NEO-BLAST: Neoadjuvant Therapy for Bladder Cancer Followed by Active Surveillance vs Treatment
Is NCT06537154 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies non-drug interventions for muscle-invasive bladder carcinoma.
Invasive bladder cancer is managed with neoadjuvant therapy followed by bladder removal (cystectomy). Research shows that approximately 40% of patient will have no remaining cancer left in their bladder after completion of the initial systemic treatment, and perhaps could have avoided the surgery. However, currently physicians lack the ability to identify these patients. The investigators believe that by using advanced imaging (MRI), bladder biopsies and novel biomarkers that detect tumor DNA in blood, they can better identify participants without any remaining cancer after chemotherapy. This will make active surveillance of these participants safer. In this study, participants without evidence of residual cancer will be randomized to active surveillance vs conventional bladder treatment (bladder removal, or chemo-radiation of the bladder). This study will be a pilot randomized control trial (RCT), and if successful, it will transition to a larger phase 3 RCT.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic chemotherapy
Prior systemic chemotherapy
Cannot have received: immunotherapy (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4)
Prior immunotherapy (an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
Cannot have received: antibody-drug conjugate (NECTIN-4, HER2)
antibody-drug conjugate (NECTIN-4, HER2 or other)
Cannot have received: cytotoxic chemotherapy
cytotoxic chemotherapy, immunotherapy or other targeted therapy for another malignancy within 2 year of study entry
Cannot have received: radiation therapy
Prior radiation therapy for bladder cancer
Cannot have received: experimental agents
Participants who have received experimental agents within 4 weeks of study entry
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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